Keeping Track: US FDA's Rejection Of First RMAT BLA Blemishes Otherwise Positive Week Of Non-Oncology News
The latest non-oncology drug development news and highlights from our US FDA Performance Tracker.
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Tropical diseases were not neglected by the Center for Biologics Evaluation and Research in 2019, producing three novel vaccines (which earned three priority review vouchers) and tilting the approval class toward expedited review programs.
A number of new products have been submitted for review at the European Medicines Agency. While marketing authorization applications from ViiV Healthcare and BioMarin Pharmaceutical are being fast-tracked, a submission from Incyte is not.
The US FDA issued at least 33 complete response letters to sponsors in 2019, although only one went to a biosimilar candidate.